SAVA Jumps From $7 To $75 In Just 3 Weeks, DRRX Gets FDA Nod, IMVT Pauses Trials, OCGN Catches Eye

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Today's Daily Dose brings you news about encouraging results of Cassava's Alzheimer's trial; FDA approval of DURECT's post-operative pain relief depot product, Posimir, Immunovant pausing IMVT-1401 trials and Travere's pivotal study of Sparsentan in focal segmental glomerulosclerosis yielding positive results.

Read on…

1. Cassava Hits New High On Encouraging Alzheimer's Trial Data

Shares of Cassava Sciences Inc. (SAVA) soared more than 140% on Tuesday, thanks to encouraging interim analysis results from the company's ongoing one-year, open-label safety study of its lead drug candidate Simufilam for the treatment of Alzheimer's disease.

The open label study, which is funded by the National Institutes of Health, is evaluating the long-term safety and tolerability of Simufilam 100 mg twice daily in patients with mild-to-moderate Alzheimer's disease. This study, initiated in March 2020, with the enrollment target of 100 patients, is now approximately 80% enrolled.

According to the interim analysis results, reported Tuesday, the patients' cognition and behavior scores both improved following six months of Simufilam treatment, with no safety issues.

The cognition scores improved by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6. Similarly, dementia-related behavior, such as anxiety, delusions and agitation, improved by 1.3 points on the Neuropsychiatric Inventory, a 29% mean improvement from baseline to month 6.

ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale) is a standard test for assessing changes in cognition in Alzheimer's disease trials. NPI (Neuropsychiatric Inventory) is a widely used tool for measuring changes in dementia-related behavior.

In 2019, Cassava announced positive results from an open-label phase IIa study of Simufilam in Alzheimer's disease and in the following year, i.e., 2020, announced positive results of a randomized, placebo-controlled phase IIb study of Simufilam in Alzheimer's disease.

The company plans to initiate a phase III trial of Simufilam in Alzheimer's disease in the 2nd half 2021.

SAVA touched an all-time high of $74.50 in intraday trading Tuesday, before closing at $55.44, up 141.15%. The stock was trading around $7 on Jan.4, 2021, i.e., the first day of trading of this year.

When we had alerted readers to this stock on Dec.30, 2019, it was trading around $5.

Related Reading

Cassava Sciences (SAVA) Is Up 200% In 6 Days, What's The Buzz?

2. Finally, FDA Approves DURECT's Pain Relief Depot Product

DURECT Corp.'s (DRRX) post-operative pain relief depot product, Posimir, for which FDA approval has been sought since 2013, finally made it to the finish line on Tuesday.

POSIMIR has been approved by the FDA for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.

Posimir is formulated as a 12% solution (132 mg bupivacaine/mL) with a maximum administration volume of 5 mL allowing for 660 mg of a non-opioid local analgesic Bupivacaine to be instilled within a site.

Commenting on the approval, T J Gan, Professor and Distinguished Endowed Chair, Department of Anesthesiology at Stony Brook University Renaissance School of Medicine, said, "The first 72 hours after surgery are typically when patients experience the most severe postsurgical pain. So, a new sustained-release product providing continuous analgesia during this critical period is a welcome addition to the armamentarium for anesthesiologists and surgeons, especially as we aim to reduce the use of postsurgical opioids whenever possible."

DRRX closed Tuesday's trading at $2.48, up 18.10%.

3. Immunovant Pauses Dosing of IMVT-1401 Trials

Shares of Immunovant (IMVT) plunged nearly 43% on Tuesday, on news of the company announcing that it is pausing the dosing of ongoing clinical trials for IMVT-1401, which is being developed for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

The decision to pause dosing of IMVT-1401 trials was taken after the company became aware of a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT-1401-treated patients in a phase IIb trial in Thyroid Eye Disease, dubbed ASCEND GO-2.

In the ASCEND GO-2 trial, mean LDL cholesterol at week 12 was increased by approximately 65% in the 680mg dose group, by approximately 40% in the 340mg dose group, and did not increase in the control group.

IMVT-1401 is also being studied in a phase IIa trial in Warm Autoimmune Hemolytic Anemia, dubbed ASCEND WAIHA. The company has decided to voluntarily pause dosing in both the ongoing clinical studies ASCEND GO-2 and ASCEND WAIHA.

A phase III trial of IMVT-1401 in Myasthenia Gravis is expected to be initiated in the first half of this year.

Harbour BioMed, the license holder for IMVT-1401 in Greater China, has informed Immunovant that based on their preliminary review of blinded data in their ongoing clinical studies in Chinese patients with Myasthenia Gravis and Idiopathic Thrombocytopenic Purpura, similar increases in cholesterol have not been observed.

After discussion and agreement with regulators about study protocol changes, the company intends to continue to pursue development of IMVT-1401.

IMVT closed Tuesday's trading at $25.08, down 42.08%.

4. Moleculin Soars on Annamycin's Efficacy in Osteosarcoma Lung Metastases Animal Model

Moleculin Biotech Inc.'s (MBRX) lead drug candidate Annamycin has demonstrated 100% survival rate in osteosarcoma lung metastases animal model.

Osteosarcoma is among a class of tumors that initiate in the bone of patients, with bone-related sarcomas representing the second most common form of sarcoma after soft tissue sarcoma. It is estimated that at least 40% of bone sarcomas will eventually metastasize to the lungs, where treatment can become more problematic. Researchers have more recently referred to the lungs and certain other vital organs as "sanctuary sites" for cancer where tumors can develop out of reach from conventional chemotherapies, noted the company.

The company received FDA clearance as recently as December 29, 2020, to initiate a Phase 1B/2 clinical trial of Annamycin in the US for patients with soft tissue sarcoma that has metastasized to the lungs after first-line therapy for their disease. This trial is expected to be initiated this year.

A 1-for-6 reverse stock split was implemented by the company on February 1, 2021.

MBRX closed Tuesday's trading at $6.39, up 35.96%.

5. Ocugen, Bharat Biotech To Co-develop Covaxin For U.S. Market

Ocugen Inc. (OCGN) and India's Bharat Biotech have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech's COVID-19 vaccine, Covaxin, for the United States market.

Bharat Biotech secured emergency use approval for Covaxin in India as recently as January 3, 2021. Covaxin is currently in phase III trials in India.

OCGN closed Tuesday's trading at $3.26, up 80.11%.

6. Travere's DUPLEX Study Makes A Mark

Travere Therapeutics Inc.'s (TVTX) ongoing pivotal phase III study of Sparsentan in focal segmental glomerulosclerosis, dubbed DUPLEX, has yielded positive results.

Focal Segmental Glomerulosclerosis is a kidney disorder characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression.

In the DUPLEX study, a total of 371 patients were randomized 1:1 to receive either Sparsentan or Irbesartan, the active control. Irbesartan, sold under brand name Avapro, is used to treat high blood pressure and protect kidney function in diabetic patients who have protein loss. Irbesartan is part of a class of drugs used to manage focal segmental glomerulosclerosis and IgA nephropathy in the absence of an approved pharmacologic treatment.

In the DUPLEX study, Sparsentan achieved statistically significant response on interim proteinuria endpoint compared to Irbesartan after 36-weeks of treatment.

The DUPLEX Study is fully enrolled and will continue to assess the confirmatory estimated glomerular filtration rate (egfr) endpoint after 108 weeks of treatment, with topline results of the confirmatory endpoint expected in the first half of 2023.

Sparsentan is also being evaluated for the treatment of IgA nephropathy in a pivotal phase III study, dubbed PROTECT, and topline efficacy data from the 36-week interim proteinuria endpoint analysis from that study are anticipated in the third quarter of 2021.

TVTX closed Tuesday's trading at $28.79, up 11.24%.

7. Some of the Top Gainers/Losers

Annovis Bio Inc. (ANVS) closed Tuesday's trading at $16.60, up 61.95%.

Vaxart Inc. (VXRT) closed at $23.33, up 49.84%.

SELLAS Life Sciences Group, Inc. (SLS) closed at $8.18, up 34.10%.

Fulgent Genetics Inc. (FLGT) closed at $112.83, down 18.19%.

CEL-SCI Corporation (CVM) closed at $22.72, down 17.80%.

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